DNA Test for Alzheimer’s Risk (And 9 Other Diseases) Approved by FDA

What would you do if you found out you were at a high risk of developing Alzheimer’s or Parkinson’s? Would you prepare long-term for what might happen, or just carry on with your normal life? You might need to start thinking about answers to these questions.

This past week, 23andme received FDA approval for genetic testing kits that the California-based company will use to analyze your risk factors for 10 major disease conditions.

Back in 2013, the FDA banned the 23andme DNA tests, and it has been working closely with the company to make sure that they have taken every necessary precaution to avoid customer confusion. “Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”

Each DNA test requires the customer send a saliva sample for analysis. The DNA contained in the sample is checked against a half million or so genetic variants, and the associated risk is calculated based on the presence or absence of certain markers.